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510(k) K182654

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card by Safecare Biotech (Hangzhou) Co., Ltd. — Product Code NGG

K182654 is an FDA 510(k) premarket notification submitted by Safecare Biotech (Hangzhou) Co., Ltd. for the device "SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card". The FDA issued a decision of Substantially Equivalent on November 19, 2018. The device falls under product code NGG (Test, Methamphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3610. Safecare Biotech (Hangzhou) Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2018
Date Received
September 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Methamphetamine, Over The Counter
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by Safecare Biotech (Hangzhou) Co., Ltd.

  • K242767 — Safecare Urinary Tract Infection Test (January 10, 2025)
  • K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette (April 10, 2024)
  • K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (March 24, 2021)
  • K200133 — hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (August 13, 2020)
  • K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (May 27, 2020)
  • K191924 — SAFECARE® THC Urine Strip Test (August 16, 2019)
  • K181968 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card (August 20, 2018)
  • K153646 — SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Tes (March 18, 2016)

FDA data resources